Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

AI/ML Overview

The provided document describes the Mediaid SpO2 Sensor and its clearance. However, it does not include detailed acceptance criteria or a comprehensive study report with all the requested information. The document focuses on demonstrating substantial equivalence to predicate devices based on a clinical hypoxia study and other tests.

Here's the information that can be extracted and a summary of what is not present:

Missing Information:

Specific numerical acceptance criteria for SpO2 accuracy (e.g., A_rms value, range of acceptable deviation).
Specific numerical acceptance criteria for pulse rate accuracy.
The exact "reported device performance" against those criteria.
Sample size used for the test set beyond "2 or subjects" which is likely a typo for "20 subjects".
Data provenance details like country of origin for the clinical hypoxia study.
Number of experts, their qualifications, or adjudication methods for ground truth, especially for the clinical hypoxia study.
Whether an MRMC comparative effectiveness study was done, or its effect size.
Sample size for the training set or how its ground truth was established, as this is a standalone device without an explicit AI/ML component described for training.

Available Information from the Document:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format with numerical criteria and corresponding reported performance. The document generally states that the device was "found to be equivalent to predicate sensors" and "2 or [likely "20"] subjects" were tested.
Sample sized used for the test set and the data provenance:
- Sample Size (Test Set): "2 or subjects" (likely a typo, intended to be "20 subjects")
- Data Provenance: Clinical hypoxia studies conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The study was retrospective or prospective is not stated, but clinical hypoxia studies are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not specified. The ground truth was established by an "arterial blood co-oximeter." Experts might have been involved in the operation or interpretation, but their role in establishing "ground truth" (beyond operating the co-oximeter) is not detailed.
Adjudication method for the test set: This information is not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC comparative effectiveness study was not done, and there is no mention of AI assistance in this context, as the device is an SpO2 sensor, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance was evaluated in a standalone manner as an SpO2 sensor. The "clinical hypoxia studies" compared the sensor's readings to arterial blood co-oximetry. It's an algorithm-only performance in the sense that the sensor produces a reading directly.
The type of ground truth used:
- For oxygen saturation (SpO2): Arterial blood co-oximeter
- For pulse rate: Samples were analyzed on a "facorater J ou vi [likely a typo for a type of device or method] performed to verify pulse rate accuracy." Further details on this are not provided.
The sample size for the training set: This is a physical sensor, not an AI/ML model that typically requires a "training set" in the computational sense. Therefore, this concept does not apply directly to the information provided. The development process would involve calibration and internal testing, but not a "training set" as understood in a machine learning context.
How the ground truth for the training set was established: See point 8. Not applicable in the context of this device and information provided.

Summary of Device Performance Study (as described):

The Mediaid SpO2 Sensors were evaluated through "clinical hypoxia studies" conducted in an "independent research lab."

Methodology: The SpO2 sensors were compared directly to an "arterial blood co-oximeter," which served as the ground truth.
Outcome: The sensors were "found to be equivalent to predicate sensors" based on this comparison.
Pulse Rate: "Samples analyzed on a facorater J ou vi performed to verify pulse rate accuracy."
Other Tests: Biocompatibility, electrical safety, and EMC testing were also performed to demonstrate conformance with established industry standards.

Summary

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K041964

Appendix C Page 1 of 1

SEP 1 4 2004

510(k) Summary

Submitter Information:

Mediaid, Inc. 4025 Spencer St., Suite 103 Torrance, CA 90503

Contact:

Mahesh Patel, COO Telephone: 310-793-8844 Fax: 310-793-8740

Date Prepared: July 15, 2004

Product Name:

Common Name: SpO2 Sensor (accessory to pulse oximeter)

Predicate Device:

Mediaid (formerly Palco) currently markets its own pulse oximetry system under K994372 and K911191. Mediaid wishes to extend its product line to include its own brand of pulse oximeter sensors that are compatibile with Nellcor, BCI, and Datex pulse oximeters. Nellcor, BCI, and Datex pulse oximeter sensors are marketed under K863784, K030930, K962156, and K983684, K991823, and K991823.

Description:

Intended Use:

Mediaid SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

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Comparison to Predicate Device:

Mediaid SpO2 Sensors use the same theory and principle of operation as the predicate Mevice. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims.

Performance Data & Conclusions:

2 or s which was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid SpO2 sensors were compared to arterial blood mucpendent research fab. Theatars Specieseter and found to be equivalent to predicate Samples analyzed on a facorater J ou vi formed to verify pulse rate accuracy.

Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

Mediaid, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road # 200-207 Plano, Texas 75025

Re: K041964

Trade/Device Name: Mediaid SpO2 Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 10, 2004 Received: September 10, 2004

Dear Ms. Oakes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Oakes

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled on that your device complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally receital statutes and regaratests, including, but not limited to: registration You must comply with an the Act 3 roquite.com/s/21/centers/2017); good manufacturing practice and if the (21 CFR Part 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailoring your device of your device to a premarket nothleation. The I Dr mining or sassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your do roo su caracter also, please note the regulation please contact the Online of Comphanes an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manatactacions , 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clive

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix B Page 1 of 1

Statement of Indications For Use

K641964 510(k) # Device Name: Mediaid SpO2 Sensor

Indications for Use:

The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Auu Sulion

(Division Sign-Off) (Division Sign-Ont
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041484

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).